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510(k) Data Aggregation
(370 days)
The µTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the uTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (≥ 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.
The uTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the µTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment.
The µTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The uTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument.
The Wako uTASWako AFP-L3 Calibrator Set is designed to be used with the Wako µTASWako AFP-L3 Immunological Test System for the quantitative determination of AFP-L3% in human serum.
The Wako µTASWako AFP-L3 Control L is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako µTASWako AFP-L3 Immunological Test System.
The Wako uTASWako AFP-L3 Control H is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako uTASWako AFP-L3 Immunological Test System.
The Wako µTASWako DCP Calibrator Set is designed to be used with the Wako uTASWako DCP Immunological Test System for the quantitative determination of DCP in human serum.
The Wako µTASWako DCP Control L is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako µTASWako DCP Immunological Test System.
The Wako µTASWako DCP Control H is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako uTASWako DCP Immunological Test System.
The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that can perform assays of the uTASWako AFP-L3 and µTASWako DCP Immunological Test Systems. This system automatically conducts sampling, mixing, separation, and fluorescence detection on a microfluidic chip to achieve high sensitivity and accuracy. The instrument contains an automated liquid dispenser, temperature controlled reagent container, chip station, analysis compartment, and sample rack station. The outside panel has a printer and a touch panel with a menu to order measurements and to check the availability for reagent, chip, wash solution, and pure water. A chip is used for each test and is disposable. The instrument is designed to automatically and constantly monitor the reagents, chips, dispensing system and the measurement process so that measurement results are not given when an error occurs.
The system is comprised of the following products:
uTASWako i30
uTASWako AFP-L3, Calibrator Set, Control L and Control H
uTASWako DCP, Calibrator Set, Control L and Control H
Instrument and assay accessories as per labeling
The provided text describes the performance data for the µTASWako i30 Immunoanalyzer System and its associated AFP-L3 and DCP immunological test systems. This is a medical device, and the criteria and studies described relate to analytical performance, not clinical diagnostic accuracy or reader studies with human experts.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (LoD) | Not explicitly stated; "distinguished from blank" implied. | AFP-L1: 0.030 ng/mLAFP-L3: 0.028 ng/mLDCP: 0.042 ng/mL |
| Linearity/Reportable Range | "Full assay linearity was demonstrated" over claimed ranges. | Total AFP: 0.3 - 1000 ng/mLAFP-L3%: 0.5 - 99.5%DCP: 0.1 - 950 ng/mL |
| High Dose Hook Effect | "No effect" of high concentration. | Total AFP (for AFP-L3 assay): No effect up to 1,272,000 ng/mLDCP (for DCP assay): No effect up to 23,000 ng/mL |
| Within-Run Precision | Total AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% (≥ 1 ng/mL), within 15% (< 1 ng/mL) | Total AFP: 0.7% to 1.5%AFP-L3%: 0.3% to 5.6%DCP: 1.1% to 6.7% |
| Total Precision | Total AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% (≥ 1 ng/mL), within 15% (< 1 ng/mL) | Total AFP: 1.4% to 3.1%AFP-L3%: 0.4% to 6.3%DCP: 1.3% to 7.9% |
| Reproducibility (Instrument to Instrument) | Total AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% | Total AFP & AFP-L3%: 1.6% to 2.7%DCP: 4.9% to 5.6% |
| Recovery | Not explicitly stated; "evaluated the accuracy" implies acceptable recovery. | Total AFP: 97.8% to 104.9%AFP-L3%: 98.1% to 100.9%DCP: 94.0% to 111.6% |
| Interference | "No significant effect" from potential interferents. | Total AFP & AFP-L3%: No significant effect from various interferents.DCP: No significant effect from various interferents (glucose and galactose not tested for DCP). |
| HAMA Interference | "No significant effect" from HAMA interferents. | No significant effect for Total AFP, AFP-L3%, and DCP assays. |
| Method Comparison/Correlation | "Acceptable correlation" with predicate device; Specific concordance rates for clinical cut-offs. | AFP-L3%: Concordance rate of 90.4% (at 10% clinical cut-off) between µTASWako i30 and LiBASys.DCP: Concordance rate of 95.5% (at 7.5 ng/mL clinical cut-off) between µTASWako i30 and LiBASys. |
| Stability | "Demonstrated stability according to the labeled storage conditions." | Long-term stability and stability after opening for reagent, calibrator set, and controls demonstrated. 30-day stability of one-time instrument calibration also supported. |
2. Sample Size Used for the Test Set and Data Provenance
- Sensitivity (LoD): Sample size not specified, but involved distinguishing analytes from blank.
- Linearity/Assay Reportable Range: Sample size not specified.
- High Dose Hook Effect: Sample size not specified.
- Within-Run Precision: Samples with Total AFP 10-950 ng/mL, AFP-L3% 6-80%, DCP 0.2-910 ng/mL. Number of runs/replicates not specified in summary.
- Total Precision: 7 pooled human serum samples and 2 levels of controls. Samples with Total AFP 10-950 ng/mL, AFP-L3% 6-80%, DCP 0.2-910 ng/mL. Measured over 21 days.
- Reproducibility (Instrument to Instrument): 24 instruments were used. Sample details not explicitly stated, but for AFP-L3 and DCP assays.
- Recovery: Sample details not explicitly stated.
- Interference: Tested with known amounts of various interfering substances. Sample details not explicitly stated.
- HAMA Interference: Tested with two types of HAMA interferents. Sample details not explicitly stated.
- Method Comparison/Correlation (AFP-L3 and DCP):
- Test Set: 200 samples from 100 patients.
- Additionally:
- AFP-L3: 40 serum samples spiked with AFP-L1 and AFP-L3.
- DCP: 20 serum samples spiked with DCP.
- Data Provenance: Not explicitly stated, but the studies were conducted to support a US FDA 510(k) submission, suggesting a focus on samples relevant to the intended patient population, likely from clinical settings. It is retrospective in the sense that the samples are collected and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the analytical performance of an in vitro diagnostic (IVD) device. The "ground truth" for these types of studies is based on the quantitative measurement of analytes and comparison to a legally marketed predicate device (LiBASys instrument with LBA AFP-L3 and LBA DCP test systems). Therefore, human expert judgment in the diagnostic sense (e.g., radiologists interpreting images) is not applicable or described in this context. The "ground truth" for the method comparison studies would be the results obtained from the predicate device (LiBASys).
4. Adjudication Method for the Test Set
Not applicable. The studies described are analytical performance studies, not subjective diagnostic interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an IVD immunoassay system, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented is inherently "standalone" in the context of the device's function, as it evaluates the instrument and test systems' analytical capabilities directly. The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that performs sampling, mixing, separation, and fluorescence detection. Its output (quantitative measurements of AFP-L3% and DCP) does not involve human interpretation in the same way an AI imaging algorithm would. The method comparison studies compare the new device's automated results directly against a predicate automated device.
7. The Type of Ground Truth Used
The ground truth for the analytical performance studies is largely based on:
- Reference Standards: For sensitivity and linearity, the accurate measurement of known concentrations of analytes.
- Predicate Device Results: For the method comparison/correlation studies, the results obtained from the legally marketed predicate devices (LiBASys instrument with LBA AFP-L3 and LBA DCP test systems) are used as the comparative "ground truth."
- Clinical Cut-off Values: For calculating concordance rates (e.g., 10% for AFP-L3%, 7.5 ng/mL for DCP), these are established clinical values, not derived from a de novo ground truth for the study but rather applied to the measured values.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI development. These are validation studies for an IVD device. The methods described include validation of reagents, calibrators, and system performance through various analytical tests (precision, linearity, recovery, etc.).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The studies conducted are for analytical validation of an IVD system against established analytical performance metrics and comparison to a predicate device.
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(183 days)
The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.
APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.
The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
The provided text describes the Wako Diagnostics APOLOWAKO Lipid Panel and Analyzer, a point-of-care test system designed for the quantitative determination of total cholesterol, HDL cholesterol, and triglycerides in whole blood, with calculated LDL cholesterol. The device aims for substantial equivalence to the CHOLESTECH LDX system.
Here's an analysis of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, the performance characteristics (imprecision, linearity, interference) of the APOLOWAKO system are compared against or shown to be superior to those of the predicate device (Cholestech LDX) and demonstrate acceptable analytical performance. The substantial equivalence conclusion is based on comparable or better performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implicit, based on Predicate or generally acceptable analytical performance) | Reported Device Performance (APOLOWAKO Lipid Panel) |
|---|---|---|
| Triglycerides | ||
| Within-day Imprecision | %CV comparable to or better than predicate (Pred: < 3.2% CV) | 0.5% CV to 2.9% CV |
| Between-day Imprecision | %CV comparable to or better than predicate | 0.9% CV to 1.8% CV |
| Linearity | Linear throughout reportable range | Linear throughout reportable range |
| Interference | No interference from common interferents | No interference from hemoglobin, bilirubin, free glycerol. |
| Total Cholesterol | ||
| Within-day Imprecision | %CV comparable to or better than predicate (Pred: < 4.0% CV) | 0.5% CV to 1.2% CV |
| Between-day Imprecision | %CV comparable to or better than predicate | 0.6% CV to 1.7% CV |
| Linearity | Linear throughout reportable range | Linear throughout reportable range |
| Interference | No interference from common interferents | No interference from hemoglobin, bilirubin, triglycerides, ascorbic acid, EDAT-2Na, heparin sodium. |
| HDL-C | ||
| Within-day Imprecision | %CV comparable to or better than predicate (Pred: < 6.5% CV) | 0.5% CV to 1.6% CV |
| Between-day Imprecision | %CV comparable to or better than predicate | 0.5% CV to 1.6% CV |
| Linearity | Linear throughout reportable range | Linear throughout reportable range |
| Interference | No interference from common interferents | No interference from hemoglobin, bilirubin, triglycerides, ascorbic acid, EDAT-2Na, heparin sodium. |
| Method Comparison | Clinically significant correlation with reference methods (slopes approaching 1.0, y-intercepts approaching zero, correlation coefficient ≥ 0.945) | Correlation coefficients of 0.945 or better for each assay (with reference methods). Slopes approaching 1.0 and y-intercepts approaching zero. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Data/Method Comparison): 388 samples for Total Cholesterol and Triglycerides. 384 samples for HDL-cholesterol (4 samples out of detectable range).
- Data Provenance: Not explicitly stated, but the study refers to "rigorous conditions sufficient to meet the requirements for CLIA Waiver," which implies a clinical setting. No specific country of origin is mentioned. The study appears to be prospective as it's for premarket notification of a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for the method comparison study was established by FDA-cleared comparison (reference) methods, not by expert consensus on image interpretation or similar qualitative assessments.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The evaluation relies on quantitative measurements against reference methods, not subjective adjudication of results.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is a diagnostic device for quantitative chemical analysis, not an imaging or qualitative assessment device that would typically involve human readers or AI assistance in interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the device's performance as a standalone analytical instrument is demonstrated through the non-clinical (imprecision, linearity, interference) and clinical (method comparison) studies. It performs the measurements and calculations independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: For the clinical data (method comparison study), the ground truth was established by FDA-cleared comparison methods (reference methods) for total cholesterol, triglycerides, and HDL-cholesterol.
8. The sample size for the training set:
- Training Set Sample Size: Not explicitly mentioned. For this type of chemical analyzer, the "training" (calibration and initial validation of reagents) is inherent in the design and manufacturing process, and performance is demonstrated through studies on defined analytical controls and clinical samples. It's not a machine learning model with a distinct "training set" in the traditional sense. Calibration is performed when the reagent is opened.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: The document mentions "lyophilized calibrator" included in each reagent unit. This calibrator, traceable to recognized standards, would establish the ground truth for the calibration process and ensure accurate measurement by the device. The methodology is enzyme-based colorimetric, requiring calibration against known concentrations.
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(182 days)
The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.
Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
The Wako Diagnostics APOLOWAKO HbA1c and APOLOWAKO Glucose test systems were evaluated for their ability to quantitatively determine hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | APOLOWAKO HbA1c Performance | APOLOWAKO Glucose Performance |
|---|---|---|---|
| Intended Use | Quantitative determination of HbA1c and glucose in whole blood for monitoring diabetes and diagnosing carbohydrate metabolism disorders. | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). |
| Reportable Range | HbA1c: 4-15% Glucose: 50-500 mg/dL | HbA1c: 3-16.5% | Glucose: 18-350 mg/dL |
| Precision (Total Imprecision) | HbA1c: < 4% across 5.7%-9.4% (mean values) Glucose: < 6.5% across 103-127 mg/dL (mean values) | HbA1c: 3% or less across 4.8%-15.2% (mean values) | Glucose: Less than 2% CV across 72-540 mg/dL (mean values) |
| Linearity | Assay linear throughout reportable range | Assay linear throughout reportable range | Assay linear throughout reportable range |
| Interfering Substances | HbA1c: No interference from bilirubin, acetylsalicylic acid, caffeine, acetaminophen, hydroxyzine dihydroxychloride; elevated lipids may interfere. Glucose: Possible 6-7% difference between fingerstick and venous blood; 23 other substances had no effect. | No interference from high levels of bilirubin (conjugated and unconjugated), triglycerides, hemoglobin (for glucose only), sodium fluoride (glucose only), heparin sodium, EDTA-2Na, ascorbic acid, and others. Labile HbA1c, carbamylated hemoglobin, or acetylated hemoglobin has no influence on the HbA1c assay. | No interference from high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, heparin sodium, or sodium fluoride. |
Study that Proves Device Meets Acceptance Criteria:
The device's performance was evaluated through a combination of non-clinical and clinical studies.
2. Sample Size Used for the Test Set and Data Provenance
- HbA1c Test Set Sample Size: At least 352 samples.
- Glucose Test Set Sample Size: At least 387 samples.
- Data Provenance: Not explicitly stated, but the submission is from Wako Diagnostics, a US-based company, suggesting the studies were conducted to meet US regulatory requirements. The mention of "rigorous conditions sufficient to meet the requirements for CLIA Waiver" implies a focus on a US clinical laboratory context. The data is retrospective, derived from already collected samples used for method comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the test set was established by "FDA cleared comparison methods" and "reference method" as per the method comparison study, not by expert review of individual cases.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by comparison to reference methods, not by human expert adjudication of individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The evaluation focused on the accuracy of the device's measurements compared to predicate and reference methods, not on human reader performance with or without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was done. The non-clinical evaluations (imprecision, linearity, interfering substances) and the method comparison study directly assess the algorithm's (device's) performance without human intervention in the result generation process. The device itself is described as an "analyzer" that performs "up to six analytical tests per individual sample" and "automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement
process to ensure that no erroneous results are shown," indicating standalone operation.
7. Type of Ground Truth Used
The ground truth used for the method comparison study was established by "FDA cleared comparison methods" and "reference method." This typically implies standardized laboratory assays or methods previously validated and cleared by regulatory bodies, representing the clinical standard for measuring HbA1c and glucose.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. In the context of in-vitro diagnostic devices like this one, development and internal validation (which might involve training if machine learning was used, though not explicitly stated for this 2008 device) would precede the reported verification and validation studies. The numbers provided (352 for HbA1c, 387 for glucose) are for the clinical method comparison study, which serves as a validation set.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned, information on how its ground truth was established is not available in the provided text. For devices of this nature, ground truth for development and internal validation would typically be established using highly accurate laboratory reference methods or certified reference materials.
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